Full Enrollment Achieved in XanaCIDD Phase 2a Cognitive Function and Depression Study

Actinogen Medical Limited, an Australian biotech firm listed on the ASX (ACW), has completed the enrollment of 167 participants for its XanaCIDD phase 2a clinical trial. The study is designed to evaluate the effects of Xanamem®, a novel small molecule, on cognitive function in individuals with major depressive disorder (MDD). Unlike traditional antidepressants, Xanamem targets cognitive impairments, a common yet often untreated symptom of MDD, by reducing cortisol levels in the brain without disrupting the body's stress response.

The treatment approach involves inhibiting an enzyme called 11β-HSD1, which is responsible for cortisol synthesis in brain tissue. This method leaves the adrenal gland's cortisol production unaffected, thus preserving the body's normal stress response. Xanamem is formulated as an oral therapy, making it a convenient option for patients. The drug's potential extends beyond MDD, with possible applications in Alzheimer's disease, schizophrenia, and other forms of dementia, where cognitive impairment is a significant issue.

Dr. Dana Hilt, the company's Chief Medical Officer, expressed satisfaction with the enrollment completion and highlighted the importance of the trial. The study's robust design, which includes a placebo-controlled group and a six-week treatment duration followed by a four-week follow-up, aims to determine Xanamem's efficacy in enhancing cognitive function and its impact on depressive symptoms.

The primary measure of the trial's success is the Cogstate "attention composite" test, which assesses attention and working memory—key components of cognitive ability. The trial also employs the Montgomery-Asberg Depression Rating Scale (MADRS) to evaluate depressive symptoms, a crucial metric for regulatory approvals of antidepressant medications.

In addition to the XanaCIDD trial, Actinogen is conducting the XanaMIA phase 2b trial, a 36-week study involving patients with mild to moderate Alzheimer's disease. This trial is expected to yield interim results in mid-2025 and final outcomes in 2026.

Actinogen Medical is focused on developing therapies for neurological and neuropsychiatric conditions linked to abnormal brain cortisol levels. The company's lead compound, Xanamem, is under investigation for its potential to treat Alzheimer's disease and depression. The drug's innovative mechanism of action involves blocking cortisol production within brain cells, which could mitigate cognitive decline and cell damage associated with these conditions.

Clinical trials have shown that Xanamem can significantly improve working memory and attention in healthy older adults and enhance the cognitive and functional abilities of patients with mild Alzheimer's disease. The drug's safety profile is promising, with a low potential for drug-drug interactions, making it a versatile candidate for various diseases and patient populations.

Xanamem remains an experimental product, with its use limited to clinical trials until approved by regulatory authorities such as the FDA. The company's commitment to advancing Xanamem as a novel therapy underscores the significant unmet need for improved treatments in the field of neuropsychiatric disorders.